BEUDAMED
    FDA Recall Open, Classified

    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    Recall: Z-1517-2025 · Initiated February 26, 2025

    Recall

    Recall Number
    Z-1517-2025
    Event Number
    96430
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    February 26, 2025
    Posted
    April 3, 2025
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    Reason

    Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.

    Action

    On 02/26/2025 and 3/10/2025, the firm send "URGENT MEDICAL DEVICE RECALL" Letters dated 2/20/2025 via email and postal mail to customer. The letter described the product, problem and actions to be taken. Customer are instruction to: . The calculated results can be recalculated manually offline by users based on the formula defined and rerun results from constituent tests. . Configure calculated tests within LIS/Middleware, if available. . Beckman Coulter recommends sharing the content of this letter with your laboratory and/or Medical Director. Any questions regarding this notice, contact our Customer Support Center: . From our website: http://www.beckmancoulter.com . Troubleshooting Hotline: (800) 854-3633

    Distribution

    Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID, IL, IN, LA, MA, AI, MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI; O.U.S. (foreign) to countries of: Australia, Belgium, Bosnia/Herzegovina, Canada, Croatia, Egypt, Ethiopia, France, Germany, Ghana, India, Italy, Republic of Korea, Lebanon, Libya, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Qatar, Saudi Arabia, Seychelles, Slovakia, South Africa, Spain and Switzerland

    Quantity

    143 systems (U.S. 74 and O.U.S. 69)